Catheter assembly and a method and system for producing such an assembly

ABSTRACT

A catheter assembly is disclosed, comprising a catheter, such as a urinary catheter, which at least a partly is provided with hydrophilic coating. The catheter assembly further comprises a wetting fluid. The receptacle is in direct contact with the hydrophilic coating of the catheter over the part of the catheter with the hydrophilic coating. This may, for example, be achieved by using a shrink wrap material. In order to accomplish adequate wetting, channels or the like may be provided on the inner surface of the receptacle or the outer surface of the catheter.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.14/471,044, filed Aug. 28, 2014, and entitled “Catheter Assembly And AMethod And System For Producing Such An Assembly”, now pending, which isa continuation of U.S. patent application Ser. No. 13/331,485, filedDec. 20, 2011 and entitled “Catheter Assembly And A Method And SystemFor Producing Such An Assembly”, now abandoned, which claims the benefitof U.S. Provisional Application No. 61/426,052, filed Dec. 22, 2010 andentitled “Catheter Assembly And A Method And System For Producing SuchAn Assembly” and EP10196593.7, filed Dec. 22, 2010 and entitled“Catheter Assembly And A Method And System For Producing Such AnAssembly”, all of which are incorporated herein by reference in theirentireties.

TECHNICAL FIELD

The present invention relates to a hydrophilic catheter assemblyincluding a wetting fluid, and a method and system for manufacturingsuch an assembly. The present invention is particularly related tohydrophilic urinary catheters.

BACKGROUND

Catheter assemblies for hydrophilic catheters, including a wetting fluidfor wetting and activation of the hydrophilic catheter before use havebeen known for over a decade. In one type of such products the wettingfluid is initially kept separate from the hydrophilic surface, andreleased immediately prior to use, thereby activating the hydrophilicsurface. In another type of such products, the wetting fluid is arrangedin such a way that the hydrophilic surface is maintained constantlywetted, and thereby ready for immediate use.

The provision of the wetting fluid in the catheter assembly entails manyadvantages. For example, there is no need to find a water supply, andcatheterization can constantly be performed in any location and at anytime.

Further, the entire wetting process can be performed under sterileconditions, without opening of the package.

However, a drawback with such catheter assemblies is that the productsare relatively large and heavy and expensive to produce. In order toensure a proper wetting, a substantial amount of wetting fluid isrequired, and in most products of this type, the wetting fluid in itselfforms a substantial part of the overall weight of the product Further,the provision of large volumes of wetting fluid complicates theproduction, e.g. requiring larger doses of radiation for sterilization,and also makes logistics more complicated and expensive.

Consequently, there has for several years been a strive to developcatheter assemblies of this type requiring more limited amounts ofwetting fluid. Such attempts are e.g. disclosed in EP 1 023 882, WO2006/092150 and EP 2 106 821. However, these products still requirerelatively large amounts of wetting fluid in order to ensure adequatewetting, and the proposed products are relatively complex, therebyincreasing the manufacturing costs.

Further, there have been attempts to reduce the amount of wetting fluidby proposing complex wetting procedures, where a limited amount ofwetting fluid is moved back and forth in order to entail a properwetting. Such solutions are e.g. disclosed in US 2005/0109648 and US2004/0074794. However, these methods of wetting are relativelycomplicated, making the wetting process tedious and difficult to performby e.g. disabled users. Further, there is a significant risk that aninadequate wetting would occur from time to time, which would be bothpainful and potentially harmful for the user.

There is therefore still a need for a hydrophilic catheter assemblyensuring an adequate wetting and which is less large and heavy and/orless easier and less costly to produce and distribute.

SUMMARY

There is therefore an object of the present invention to provide acatheter assembly and a method of manufacture that at least partlyovercome the above-discussed problems of the prior art.

This object is achieved by means of a catheter assembly and a method andsystem for manufacture according to the enclosed claims.

According to a first aspect of the invention, there is provided acatheter assembly comprising:

-   -   a catheter, at least a part of which is provided with a        hydrophilic coating;    -   a wetting fluid; and    -   a receptacle enclosing the wetting fluid and at least the part        of the catheter being provided with the hydrophilic coating;    -   wherein the receptacle is in direct contact with the hydrophilic        coating of the catheter over essentially the entire length of        said part of the catheter being provided with the hydrophilic        coating.

The catheter assembly consequently provides a receptacle which verynarrowly encloses the part of the catheter being provided with thehydrophilic coating. This results in a very lean and light product,where a very limited amount of water is sufficient to ensure an easy andhighly effective wetting of the entire hydrophilic surface.

This product can also be produced at a relatively low cost. Smallersized products and less material makes it possible to use a high speedproduction. Further, due to smaller size and lower amount of wettingfluid, enhanced dose ratio properties can be obtained when radiationsterilization is used. Still further, lower weight and size result insmaller primary and secondary packages, which makes the productioneasier and less costly, and also makes the products easier and lesscostly to handle and store.

By means of the present invention, the amount of wetting liquid requiredfor appropriate wetting of the hydrophilic coating may be reduced toonly slightly more than the wetting fluid contained in the hydrophiliccoating when wetted. Consequently, a substantial part of the wettingfluid, and preferably essentially all the wetting fluid, is in this wayused for its intended purpose, viz. to be assimilated by the hydrophiliccoating.

Preferably, the direct contact between the hydrophilic coating and thereceptacle occurs in a number of contact points being distributed aroundthe circumference of the catheter, said contact points being discretecontact points or contact points being continuously connected. Bycontact points being continuously connected is in this context meantformation of one or several continuous lines of contact, wherein eachline forms a plurality or even infinite number of contact points. Sincethe contact points are distributed around the circumference of thecatheter, a very narrow spacing between the catheter and the receptacleis ensured. Preferably, the contact points are evenly distributed aroundthe circumference of the catheter. Such even distribution can either beobtained by discrete contact points being arranged with essentially thesame distance from each other, or by continuously connected contactpoints or groups of closely arranged discrete points being provided atessentially the same distance from each other.

It has surprisingly been found by the present inventor that for manytypes of hydrophilic coatings, the wetting fluid will distribute withinthe coating without the need for external passageways.

However, in order to make the distribution of the wetting fluid withinthe package faster and more efficient, it is preferred to arrangepassageways for the wetting fluid between the hydrophilic coating andthe receptacle. Preferably, at least one of the inner surface of thereceptacle facing the hydrophilic coating and the outer surface of thehydrophilic coating, facing the receptacle comprises a surface textureforming channels between the receptacle and the hydrophilic coating, theareas between the channels forming areas of direct contact between thereceptacle and the hydrophilic coating.

Preferably, a substantial part of the hydrophilic coating is in directcontact with the receptacle. It is also preferred that at least 20% ofthe area of the hydrophilic coating is in direct contact with thereceptacle, and even more preferably at least 30%, and most preferablyat least 50%.

The catheter assembly of any one of the preceding claims, wherein thereceptacle comprises a shrink-wrap film or package. Hereby, theprovision of the contact between the hydrophilic coating and thereceptacle becomes very easy to obtain. Packaging can be made in arelatively large receptacle, which is subsequently shrunk to a morecompact state by the provision of heat. Such a catheter assembly lendsitself very well for a high speed automated manufacturing process.

In order to facilitate opening of the package, for withdrawal of thecatheter before use, the receptacle is preferably provided with areas orlines of weakness for facilitating opening of the receptacle. Further,tabs for tearing may be provided to further facilitate opening.Additionally or alternatively, other opening means may be provided, suchas peelable openings and the like.

In one line of embodiments, the wetting fluid is arranged separate fromthe hydrophilic coating, said wetting fluid being releasable for wettingof the hydrophilic coating before use. For example, the wetting fluidmay be arranged in a separate compartment formed in the receptacle, orin a separate wetting fluid container arranged fully or partly withinthe bounds of the receptacle. The release of the wetting fluid may beaccomplished by means of applying a pressure on the wetting fluidcompartment. Other actions for releasing of the wetting fluid mayhowever also be used, such as twisting, bending, pulling and the like.

In another line of embodiments, the wetting fluid is arranged in directcontact with the hydrophilic coating, maintaining the hydrophilic in awetted state. Hereby, the receptacle forms a compartment holding boththe wetting fluid and at least the part of the catheter being providedwith the hydrophilic coating. The wetting fluid may be provided in anamount immediately wetting and activating the catheter. However, it isalso possible to provide the wetting fluid in an amount and form whichgradually wets and activates the hydrophilic coating during an initialstorage period.

The wetting fluid is preferably an aqueous liquid, such as water or anaqueous solution comprising an osmolality increasing agent, such assaline. However, at least in embodiments where the hydrophilic coatingis maintained in a wetted state, it is also possible to use a wettingfluid in gaseous form.

According to another aspect of the invention, there is provided a methodfor manufacturing a catheter assembly, comprising the steps:

-   -   providing a hydrophilic catheter;    -   providing a wetting fluid;    -   arranging a receptacle around the wetting fluid and at least a        part of the catheter; and    -   applying heat to the receptacle, thereby making it shrink,        whereby the receptacle, at least partly comes into direct        contact with the catheter.

With this aspect of the invention, similar advantages as discussed abovein relation to the first aspect are obtainable. Further, the specificembodiments discussed in relation to the first aspect are alsocombinable with this second aspect of the invention.

According to still another aspect of the invention, there is provided asystem for manufacturing a catheter assembly, comprising:

-   -   means for enclosing a wetting fluid and a hydrophilic catheter        in a receptacle; and    -   means for applying heat to the receptacle, thereby making it        shrink, whereby the receptacle, at least partly comes into        direct contact with the catheter.

With this aspect of the invention, similar advantages as discussed abovein relation to the first aspect are obtainable. Further, the specificembodiments discussed in relation to the first aspect are alsocombinable with this second aspect of the invention.

These and other aspects of the invention will be apparent from andelucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

For exemplifying purposes, the invention will be described in closerdetail in the following with reference to embodiments thereofillustrated in the attached drawings, wherein:

FIG. 1A is a side view showing a catheter assembly according to a firstembodiment of the present invention in an intermediate production step.

FIG. 1B is a side view showing the catheter assembly of FIG. 1A in afinal configuration.

FIG. 2A shows a cross-section of one embodiment of catheter assemblyaccording to the present invention.

FIG. 2B shows a cross-section of another embodiment of catheter assemblyaccording to the present invention.

FIG. 2C shows a cross-section of another embodiment of catheter assemblyaccording to the present invention.

FIG. 20 shows a cross-section of another embodiment of catheter assemblyaccording to the present invention.

FIG. 3A shows another cross-section of an embodiment of a catheteraccording to the invention.

FIG. 3B shows a side-view of a cut out part of the catheter assembly ofFIG. 3A.

FIG. 4A shows another cross-section of an embodiment of a catheteraccording to the invention.

FIG. 4B shows a side-view of a cut out part of the catheter assembly ofFIG. 4A.

FIG. 5 shows a side view of another embodiment of a catheter assemblyaccording to the invention.

FIG. 6 shows a side view of another embodiment of a catheter assemblyaccording to the invention.

FIG. 7 shows a side view of still another embodiment of a catheterassembly according to the present invention.

FIG. 8A shows another cross-section of an embodiment of a catheteraccording to the invention.

FIG. 8B shows a side view of a cut out part of the catheter assembly ofFIG. SA.

FIG. 9 shows a side view of still another embodiment of a catheterassembly according to the present invention.

DETAILED DESCRIPTION

In the following detailed description, preferred embodiments of thepresent invention will be described. However, it is to be understoodthat features of the different embodiments are exchangeable between theembodiments and may be combined in different ways, unless anything elseis specifically indicated. It may also be noted that, for the sake ofclarity, the dimensions of certain components illustrated in thedrawings may differ from the corresponding dimensions in real-lifeimplementations of the invention, for instance the dimension of thehydrophilic coating is exaggerated. Even though in the followingdescription, numerous specific details are set forth to provide a morethorough understanding of the present invention, it will be apparent toone skilled in the art that the present invention may be practicedwithout these specific details. In other instances, well knownconstructions or functions are not described in detail, so as not toobscure the present invention.

The catheters may be used for many different purposes, and for insertioninto various types of body-cavities. However, the following discussionis in particular concerned with the preferred field of use, urinarycatheters, even though the invention is not limited to this particulartype of catheters,

With reference to FIGS. 1A and 1B, the catheter assembly comprises ahydrophilic catheter 1, i.e. a catheter which is at least partlyprovided with a hydrophilic coating. The hydrophilic coating may e.g. bepolyvinyl pyrrolidone (PVP), but many other types of hydrophiliccoatings are known in the art, and may be used in the context of thepresent invention. It is also feasible to use a catheter entirely formedof a hydrophilic material, thereby making the hydrophilic coating to bean integrally formed outer surface area of said catheter. Thehydrophilic coating provides a low-friction character to the catheterwhen wetted, thereby facilitating insertion of the catheter into theurethra, and reducing the risk of pain etc.

The hydrophilic coating is arranged on at least part of the substrateforming the catheter shaft The hydrophilic polymer coating may comprisematerial selected from polyvinyl compounds, polysaccharides,polyurethanes, polyacrylates or copolymers of vinyl compounds andacrylates or anhydrides, especially polyethyleneoxide,polyvinylpyrrolidone, heparin, dextran, xanthan gum, polyvinyl alcohol,hydroxy propyl cellulose, methyl cellulose, copolymer ofvinylpyrrolidone and hydroxy ethylmethyl acrylate or copolymer ofpolymethylvinyl ether and maleinic acid anyhydride. The preferredhydrophilic polymer is polyvinylpyrrolidone.

The hydrophilic coating preferably forms a polyurea network, wherebysaid polyurea network forms a covalent bond to said active hydrogengroups in the substrate. Alternatively, the hydrophilic coating may forman ester bond or an epoxy bond to said active hydrogen groups in thesubstrate.

The coating may also comprise an osmolality-increasing compound, as ise.g. taught in EP 0 217 771.

The elongate shaft/tube of the catheter is made of a substrate material.The substrates may be made from any polymer material, which arewell-known in the technical field and to which the said hydrophilicpolymers adhere, such as polyurethanes, latex rubbers, other rubbers,polyvinylchloride, other vinyl polymers, polyesters, polyether blockamid, polypropene, polyethen polyamide and styren-ethen/buten-styrenco-polymer and polyacrylates. However, preferably the substrate is madeof a polymer blend comprising a polyolefin and a composition havingmolecules with active hydrogen groups, and preferably a compositionhaving molecules with active hydrogen groups. The polyolefin cancomprise at least one polymer selected from the group: polyethene,polypropene, and styrene block copolymer. The composition havingmolecules with active hydrogen groups can be a polymer having activehydrogen groups bound to the polymer via nitrogen, such as polyamide orpolyurethane.

The catheter typically comprises a flared rearward portion, i.e. aconnector end 11, connected to an elongate shaft 12, wherein at leastpart of the elongate shaft is an insertable part, provided with saidhydrophilic coating on the outer surface. The connector end may functionas a connector of the catheter, being connectable to other devices, suchas a urine collection bag, a drainage tube or the like. The forward endof the elongate shaft forms a rounded tip portion 13, and an internallumen extends from the tip portion, through the elongate shaft to theconnector end. However, this is only an example of a catheter to be usedin the context of the present invention. Many other catheter types maybe used in this context as well, such as catheters having an integrallyformed funnel shaped connector end, or even without a connector.Further, the tip portion may have many different configurations, as isper se well known in the art. Further, several lumens may be provided inthe catheter, and it is also feasible to use external channels insteadof an internal lumen.

At least a part of the elongate tube forms an insertable length to beinserted through a body opening of the user, such as the urethra in caseof a urinary catheter. By insertable length is normally, in the contextof a hydrophilic catheter, meant that length of the elongate tube whichis coated with a hydrophilic material, for example PVP, and which isinsertable into the urethra of the patient. Typically, this will be50-140 mm for a female patient and 200-350 mm for a male patient.

The catheter is arranged in a receptacle 2, together with a wettingfluid 3.

The wetting fluid may either be arranged in a separate container, whichis openable before use of the catheter, for wetting of the hydrophiliccoating or in direct contact with the hydrophilic coating. In case thewetting fluid is arranged separately from the insertable part of thecatheter, the separation wall or joint could e.g. be a breakable orpeelable membrane wall, but alternative embodiments are naturallyfeasible, such as various types of detachable or openable caps orclosings. For example, the wetting fluid container may be a sachet or apouch containing the wetting fluid, and which is openable by applicationof a pressure on the sachet/pouch. However, other ways of enablingopening of the wetting fluid container are feasible, such as applicationof a pulling force, twisting, bending, etc. Preferably the wetting fluidmay be discharged without breaking or rupturing the receptacle, eventhough this may not be necessary, depending on the intended use, etc.

The wetting fluid is preferably an aqueous liquid, such as water orsaline. Such wetting fluid containers and wetting fluids are per se wellknown in the art. The wetting fluid container can e.g. be made of sheetmaterial comprising aluminum, or any other material having a moisturevapor transmission rate (MVTR) comparable to that of aluminum.

Further, the wetting fluid container may be arranged close to the distalpart of the catheter (close to a first end 23 of the package), close tothe proximal part of the catheter (close to a second end 24 of thepackage), or in any other suitable location in the assembly.

In the use situation, the user opens the wetting fluid container,preferably without opening the receptacle, so that the wetting fluidcomes into contact with the hydrophilic coating. When the hydrophiliccoating is adequately wetted, the catheter is removed from thereceptacle and inserted into the urethra.

It is also possible to provide the wetting fluid in direct contact withthe hydrophilic coating. Such an embodiment is illustrated in FIG. 7.Hereby, the hydrophilic coating remains constantly wetted duringstorage, and the catheter is consequently ready for immediate use.

The wetting fluid is preferably an aqueous liquid, such as sterilewater, saline or the like.

In the final configuration, the receptacle is in direct contact with thehydrophilic coating of the catheter over essentially the entire lengthof the part of the catheter being provided with the hydrophilic coating,as is shown in FIG. 1B. This provides a very narrow pocket housing thecatheter, thereby providing a very lean product, and also significantlyreducing the amount of wetting liquid required for appropriate wettingof the hydrophilic coating.

For easy manufacturing, it is preferred to use a receptacle comprising amaterial which is shrinkable by application of e.g. heat. Such shrinkwrap packages can e.g. be made of a material comprising or consisting ofpolyolefin. Preferably, the material comprises at least two films, whichare either crosslinked, or non crosslinked. However, other materials arealso feasible, including PVC and several other compositions. Thematerial can be of a variety of thicknesses, clarities, strengths andshrink ratios. For example, a shrink film of PVC may have a thickness inthe range 75-100 gauge (0.75-1.00 mm) and a shrink film of polyolefinmay have a thickness in the range 60-75 gauge (0.60-0.75 mm). Both PVCand polyolefin shrink films have excellent clarity and gloss, as well as40% shrink factor.

Hereby, the receptacle provides a first state, in which the internalvolume is relatively large, thereby enabling easy insertion of thecatheter and the wetting fluid in the receptacle. This is illustrated inFIG. 1A. Thereafter, and preferably after closing the receptacle, thepackage is shrunk, e.g. by application of heat to the package, therebyreducing the package to the final state, as is illustrated in FIG. 18.

Depending on e.g. the type of hydrophilic coating used and the thicknessof the hydrophilic coating, a wetting fluid will migrate and distributeadequately within the hydrophilic coating itself. If this is the case,it is possible to provide a receptacle which is in direct contact withthe hydrophilic coating over essentially the entire hydrophilic coating.This provides the narrowest receptacle possible, and consequentlyenables the use of a very low amount of wetting fluid.

However, for some types of hydrophilic coating, the migration of thewetting fluid within the coating may not be sufficient to ensure properactivation of the entire hydrophilic coating, or at least such properactivation may take too long time.

To ensure adequate wetting in a limited period of time, it is preferredto provide the direct contact between the hydrophilic coating and thereceptacle in a number of contact points being distributed around thecircumference of the catheter, wherein the contact points are discretecontact points or contact points being continuously connected. Since thecontact points are distributed around the circumference of the catheter,a very narrow spacing between the catheter and the receptacle is stillensured. Preferably, the contact points are evenly distributed aroundthe circumference of the catheter. Such even distribution can either beobtained by discrete contact points being arranged with essentially thesame distance from each other, or by continuously connected contactpoints or groups of closely arranged discrete points being provided atessentially the same distance from each other.

A number of embodiments illustrating such distributed contact pointswill now be discussed.

According to one embodiment, as illustrated in FIG. 2A, the receptacleis provided with a number of evenly separated and inwardly facing ribs21. These ribs forms protrusions protruding inwardly from the receptaclesurface, and will consequently forming the contacts between thereceptacle and the hydrophilic coating of the catheter. Between the ribs21, channels 22 are formed, which efficiently distributes the wettingfluid over essentially the entire surface of the hydrophilic coating.

Alternatively, as is illustrated in FIG. 2B, the ribs 21′ may be formedby provision of smoothly rounded channels 22′.

Additionally or alternatively, it is also feasible to provide channelsin the hydrophilic coating. Such an embodiment is illustrated in FIG.2C, where channels 15 are formed in the hydrophilic coating 14.

Additionally or alternatively, it is also feasible to provide separateextension members 4 within the receptacle, said extension membersforming a distance between the hydrophilic coating and the receptacle.Such an embodiment is illustrated in FIG. 20. The extension members cane.g. be rods or the like of a preferably flexible material.

Instead of evenly distributed contact points, it is also feasible toprovide only one or a few channels for distributing the wetting fluid inthe lengthwise direction. Such a channel 15″ may be formed in thehydrophilic coating, as is illustrated in FIGS. 3A and 3B. Additionallyor alternatively, the channel 22″ may be formed in the receptacle, as isillustrated in FIGS. 4A and 4B.

The contact points may form channels extending primarily in thelengthwise direction, as is illustrated in FIGS. 1A and 1B.Alternatively, the channels may extend helically around the catheter, asis illustrated in FIGS. 3B and 4B. However, other extensionconfigurations of the channels are also feasible.

In the embodiment illustrated in FIG. 1B, the wetting fluid container isarranged above the connector end of the catheter, i.e. opposite theinsertion end. However, it is also possible to arrange the wetting fluidcontainer above the insertion end, i.e. opposite the connector end. Suchan embodiment is illustrated in FIG. 5.

Further, in order to reduce the amount of wetting fluid necessary toadequately wet the hydrophilic coating of the catheter, it is notnecessary to make the entire receptacle narrow. The same effect isachievable as long as the part of the receptacle housing the insertablepart of the catheter is made sufficiently narrow. Consequently, otherparts of the receptacle may be still be relatively large. For example,it is possible to provide a receptacle having an enlarged portionhousing the wetting fluid container. Such an enlarged part of thereceptacle may e.g. be use for collecting the drained urine, i.e.forming a urine collection bag. Such an embodiment is illustrated inFIG. 6.

Production of the catheter assembly illustrated in FIG. 6 is stillrelatively simple. For example, only the forward part of the receptacle,i.e. the part housing the insertable part of the catheter, may beshrunk, e.g. by applying heat selectively only on this part of thereceptacle. Additionally or alternatively it is possible to use athicker material, or even a different type of material, in the differentparts of the receptacle.

The contact points may be arranged as continuous lines. However, it isalso possible to use contact points formed as separated lines,comprising groups of contact points. However, according to anotherembodiment, it is also possible to use discrete contact points beingevenly distributed over internal surface of the receptacle. Such anembodiment is illustrated in FIGS. 8A and 88. Hereby, a multitude ofchannels, each being in contact with each other, are formed.

In order to facilitate opening of the package, for withdrawal of thecatheter before use, the receptacle is preferably provided with areas orlines of weakness for facilitating opening of the receptacle. Further,tabs for tearing may be provided to further facilitate opening.

Additionally or alternatively, other opening means may be provided, suchas peel able openings and the like.

In FIGS. 1B, 5, 7 and 9, peel openings are indicated in both the top andbottom end of the receptacle. However, alternatively, openings may beprovided only on one of said side. The openings may also be tearopenings, and if tear openings are used, the openings may also beprovided at a distance from the ends.

In all the above-discussed embodiments having a wetting fluid container,it is also possible to provide the wetting fluid container with roundededges, in order to reduce the strain on the receptacle. Such anembodiment is illustrated in FIG. 9. Further, it is possible to arrangethe catheter with its insertion end or the discharge end (connector end)partly overlapping the wetting fluid container” Such an embodiment isalso illustrated in FIG. 9.

A system for manufacturing a catheter assembly of the above-discussedtype preferably comprises means for enclosing a wetting fluid and ahydrophilic catheter in a receptacle and means for applying heat to thereceptacle, thereby making it shrink, whereby the receptacle, at leastpartly comes into direct contact with the catheter.

Such and other obvious modifications must be considered to be within thescope of the present invention, as it is defined by the appended claims.It should be noted that the above-mentioned embodiments illustraterather than limit the invention, and that those skilled in the art willbe able to design many alternative embodiments without departing fromthe scope of the appended claims. In the claims, any reference signsplaced between parentheses shall not be construed as limiting to theclaim. The word “comprising” does not exclude the presence of otherelements or steps than those listed in the claim. The word “a” or “an”preceding an element does not exclude the presence of a plurality ofsuch elements. Further, a single unit may perform the functions ofseveral means recited in the claims.

1. A catheter assembly comprising: a catheter, at least a part of whichis provided with a hydrophilic coating; a wetting fluid; and areceptacle enclosing the wetting fluid and at least the part of thecatheter with the hydrophilic coating; wherein the receptacle is indirect contact with the hydrophilic coating of the catheter overessentially the entire length of said part of the catheter with thehydrophilic coating.
 2. The catheter assembly of claim 1, wherein thedirect contact between the hydrophilic coating and the receptacle occursin a plurality of contact points distributed around a circumference ofthe catheter, said contact points being discrete contact points orcontact points being continuously connected.
 3. The catheter assembly ofclaim 2, wherein the contact points are evenly distributed around thecircumference of the catheter.
 4. The catheter assembly of claim 1,wherein at least one of an inner surface of the receptacle facing thehydrophilic coating and an outer surface of the hydrophilic coatingfacing the receptacle comprises a surface texture forming channelsbetween the receptacle and the hydrophilic coating, wherein areasbetween the channels form areas of direct contact between the receptacleand the hydrophilic coating.
 5. The catheter assembly of claim 1,wherein a substantial part of the hydrophilic coating is in directcontact with the receptacle.
 6. The catheter assembly of claim 1,wherein at least 20% of the area of the hydrophilic coating is in directcontact with the receptacle.
 7. The catheter assembly of claim 1,wherein at least 30% of the area of the hydrophilic coating is in directcontact with the receptacle.
 8. The catheter assembly of claim 1,wherein at least 50% of the area of the hydrophilic coating is in directcontact with the receptacle.
 9. The catheter assembly of claim 1,wherein the receptacle comprises a shrink-wrap film or package.
 10. Thecatheter assembly of claim 1, wherein the receptacle includes areas orlines of weakness for facilitating opening of the receptacle.
 11. Thecatheter assembly of claim 1, wherein the wetting fluid is arrangedseparate from the hydrophilic coating, said wetting fluid beingreleasable for wetting of the hydrophilic coating before use.
 12. Thecatheter assembly of claim 1, wherein the wetting fluid is arranged indirect contact with the hydrophilic coating to maintain the hydrophiliccoating in a wetted state.
 13. The catheter assembly of claim 1, whereinthe catheter is a urinary catheter.
 14. A method for manufacturing acatheter assembly, comprising: providing a hydrophilic catheter;providing a wetting fluid; arranging a receptacle around the wettingfluid and at least a part of the catheter; and applying heat to thereceptacle, thereby making the receptacle shrink, whereby thereceptacle, at least partly comes into direct contact with thehydrophilic catheter.
 15. A system for manufacturing a catheterassembly, comprising: means for enclosing a wetting fluid and ahydrophilic catheter in a receptacle; and means for applying heat to thereceptacle, thereby making the receptacle shrink, whereby thereceptacle, at least partly, comes into direct contact with thehydrophilic catheter.